Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders (TEA)

Johns Hopkins University

Status: Terminated

Conditions: Gastroparesis

Treatments: Device: Sham TEA; Device: Transcutaneous Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04349891

IRB00247402

Details and patient eligibility

About

Gastrointestinal (GI) dysmotility is common in GI motility disorders, such as functional dyspepsia (FD) gastroparesis and chronic constipation. The symptoms of GI dysmotility include abdominal discomfort or pain, early satiety, nausea, vomiting, abdominal distension, bloating, anorexia and reduced bowel movement. . Medical treatment for GI motility disorders is very limited in the US. Acupuncture has frequently been used for treatment of GI ailments in Eastern countries. The most commonly used acupuncture points (acupoints) for focused treatment of GI symptoms are the Neiguan (PC6) and the Zusanli (ST36) points. Electroacupuncture (EA) at PC6 and ST36 has been reported to accelerate gastrointestinal motility in both animals and human.

Recently, the investigators have studied the feasibility of transcutaneous electroacupuncture (TEA): electrical stimulation is applied to acupoints via surface electrodes without needles, similar to the commercial available transcutaneous electrical nerve stimulation (TENS) but applied to acupoints. The investigators hypothesize that TEA as a new treatment option, improves GI symptoms in patients with FD, gastroparesis or constipation, improves GI motility and therefore improves quality of life of the patients.

The success of this project will lead to a noninvasive and convenient therapy for treating GI motility disorders. The proposed TEA method is expected to improve gastric and colonic functions and thus improve quality of life. In addition, the proposed TEA method and device are self-administrative after training during the first office visit. It provides a long-term treatment option for both FD, gastroparesis and chronic constipation.

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for FD patients

• Bothersome postprandial fullness
• Symptoms of early satiation, epigastric pain, epigastric burning during the last 3 months
• No evidence of structural disease including at upper endoscopy that is likely to explain the symptoms.
• Males and females between ages 18-80 yrs;
• Subjects with high probability for compliance and completion of the study.

Inclusion criteria for chronic constipation patients

• Satisfying Rome IV criteria for diagnosis of functional constipation;
• abdominal X-ray or anorectal manometry test during the past 3 months indicating delayed colonic transit (more than 20% ingested markers are retained) or abnormal colonic motility;
• ages 18-80 years;
• no constipation medication for a minimum of 1 week before enrollment except for rescue agents (stimulant laxatives, such as bisacodyl);
• willing to comply with the treatment regimen.

Inclusion criteria for gastroparesis patients

• At least one severe gastroparetic symptom or two moderate gastroparetic symptoms (see assessment of gastroparetic symptoms);
• Abnormal gastric emptying diagnosed during the past year;
• Males and females between ages 18-80 yrs;
• Subjects with high probability for compliance and completion of the study.
• Upper endoscopy or upper GI within last 2 years showing no evidence of gastric bezoar, stricture, or peptic ulcer.

Exclusion criteria:

• History of gastric bezoar or diverticulitis.
• Severe daily abdominal pain requiring narcotic medications.
• Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery.
• Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy;
• Surgery within the past 3 months.
• Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test).
• Those who have been treated with acupuncture or those who are familiar with acupuncture points.
• Anyone with an implantable cardiac pacemaker or defibrillator.
• unable to give informed consent;
• taking prokinetics, anticholinergic or dopaminergic agents;
• history of gastrointestinal surgery;
• pregnant or preparing to conceive a child;
• diabetes;
• allergic to skin preparation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups

TEA at ST36 and PC6 first and then sham TEA

Experimental group

Description:

Patients in this group will be treated with TEA at ST36 and PC6 for 4 weeks, followed with a 2-week washout period and another 4-week period with sham TEA.

Treatment:

Device: Transcutaneous Electroacupuncture

Device: Sham TEA

Sham-TEA and then TEA ST36 and PC6

Experimental group

Description:

Patients in this group will be treated with sham-TEA for 4 weeks, followed with a 2-week washout period and another 4-week period with TEA at ST36 and PC6.

Treatment:

Device: Transcutaneous Electroacupuncture

Device: Sham TEA